The role of pragmatism in explaining heterogeneity in meta-analyses of randomised trials: a protocol for a cross-sectional methodological review

Aves, Theresa; Allan, Katherine S.; Lawson, Daeria O.; Nieuwlaat, Robby; Beyene, Joseph; Mbuagbaw, Lawrence

doi:10.1136/bmjopen-2017-017887

Cited by 15 publications

(19 citation statements)

References 20 publications

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“…RITES was specifically designed to assess trials retrospectively for systematic reviews [ 46 ], PRECIS-2 is a tool for the prospective design of trials [ 47 , 48 ], and the earliest tool for differentiating trials was published in 2006 [ 49 ]. Work is underway to understand how the issue of efficacy or effectiveness affects heterogeneity in meta-analyses more generally [ 50 ], and this should help inform future assessment related to brief alcohol intervention. However, much of this debate is not relevant to alcohol interventions delivered via digital technology, which also finds positive effects of alcohol intervention.…”

Section: Discussionmentioning

confidence: 99%

Brief Interventions in Primary Care: an Evidence Overview of Practitioner and Digital Intervention Programmes

2018

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Purpose of the ReviewExcessive drinking is a major public health problem that adversely affects all parts of the population. Previous systematic reviews and meta-analyses have reported that brief interventions delivered in primary care are effective at reducing alcohol consumption, albeit with small effect sizes that have decreased over time. This review summarises the updated evidence base on practitioner and digitally delivered brief interventions.Recent FindingsUsing Cochrane methodology, 69 primary care brief intervention trials (33,642 participants) and 57 digital intervention trials (34,390 participants) were identified. Meta-analyses showed both approaches significantly reduced consumption compared to controls. Five trials (390 participants) compared practitioner-delivered and digital interventions directly with no evidence of difference in outcomes at follow-up.SummaryBrief interventions have the potential to impact at both individual and population levels. Future research should focus on optimising components and delivery mechanisms, and on alcohol-related harms. Digital interventions may overcome some of the implementation barriers faced by practitioner-delivered interventions.

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Section: Discussionmentioning

confidence: 99%

Brief Interventions in Primary Care: an Evidence Overview of Practitioner and Digital Intervention Programmes

2018

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“…This could be somewhat expected because of the different types of interventions used with varying effects on the respective endpoints, and to some extent because of the pragmatism in the formulation of these trials, which were designed to determine the effects of an intervention under usual or real-world conditions in contrast to ideal or controlled circumstances, as in explanatory trials. 127 Distant metastasis (DM) was not included in this NMA. Of the 59 studies, 17 (28.8%) had not reported on DM, and reporting of DM was inconsistent in 13 (22%).…”

Section: Discussionmentioning

confidence: 99%

Efficacy and Safety Evaluation of the Various Therapeutic Options in Locally Advanced Cervix Cancer: A Systematic Review and Network Meta-Analysis of Randomized Clinical Trials

Datta

Stutz

Gómez

et al. 2019

International Journal of Radiation Oncology*Biology*Physics

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Treatment options in locally advanced cervix cancer (LACC) have evolved around radiation therapy (RT) and/or chemotherapy (CT), hypoxic cell sensitizers, immunomodulators (Imm), and locoregional moderate hyperthermia (HT). A systematic review and network meta-analysis was conducted to synthesize the evidence for efficacy and safety in terms of long-term locoregional control (LRC), overall survival (OS), and grade !3 acute morbidity (AM) and late morbidity (LM). Five databases were searched, and 6285 articles (1974-2018) were screened per the Preferred Reporting Items for Systematic Reviews and Meta-analysis guidelines. Fifty-nine randomized trials in untreated LACC without surgical intervention were shortlisted. These used 13 different interventions: RT alone and/or neoadjuvant CT (NACT), adjuvant CT (ACT), concurrent chemoradiation therapy (CTRT) (weekly cisplatin [CDDP]/3-weekly CDDP/combination CT with CDDP/non-CDDP-based CT), hypoxic cell sensitizers, Imm, or HT. Odds ratios (ORs) using random effects network meta-analysis were estimated. Interventions for each endpoint were ranked according to their corresponding surface under cumulative ranking curve values. Of the 9894 patients evaluated, the total events reported for LRC, OS, AM, and LM were 5431 of 8197, 4482 of 7958, 1710 of 7183, and 441 of 6333, respectively. ORs and 95% credible intervals (CrIs) for the 2 best strategies were HT þ RT versus CTRT þ ACT (OR, 1.23; 95% CrI, 0.49-3.19) for LRC, CTRT (3-weekly CDDP) versus HTCTRT (OR, 1.14; 95% CrI, 0.35-3.65) for OS, RT þ ACT versus RT (OR, 0.01; 95% CrI, 0.00-1.04) for AM, and NACT þ RT þ ACT versus RT þ Imm (OR, 0.42; 95% CrI, 0.02-7.39) for LM. The 3 interventions with the highest cumulative surface under cumulative ranking curve values for all 4 endpoints were HTRT, HTCTRT, and CTRT (3-weekly CDDP). Articles with low risk of bias and those published during 2004 to 2018 also retained these interventions as the best. Two-step cluster analysis grouped these 3 modalities in a single distinctive NotedAn online CME test for this article can be taken at https:// academy.astro.org.

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“…Our study was the first from the perspective of the French primary care setting to use a graphic tool to illustrate that the trials on which recommendations for good clinical practice were based were not pragmatic. We chose to use the PRECIS-2 tool because it had already been used successfully for a systematic review in order to assess whether the pragmatism of the trials was a source of heterogeneity in the trial results [25]. As a prevention for a desirability bias according to our initial hypothesis of an excess of explanatory trials, the researchers had different backgrounds: an experienced general practitioner (CD-D) and a medical student (ET) independently scored the trials, whereas consensus was reached thanks to a third general practitioner (IE-A) and two biostatisticians (SE and GF) who studied the applicability of the PRECIS-2 tool [26].…”

Section: Strengths and Limitationsmentioning

confidence: 99%

How pragmatic are the randomised trials used in recommendations for control of glycosylated haemoglobin levels in type 2 diabetic patients in general practice: an application of the PRECIS II tool

Ettori-Ajasse

Tatin

Forbes

et al. 2020

Trials

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Background: Recommendations for good clinical practice have been reported to be difficult to apply in real life by primary care clinicians. This could be because the clinical trials at the origin of the guidelines are based on explanatory trials, conducted under ideal conditions not reflecting the reality of primary care, rather than pragmatic trials conducted under real-life conditions. The objective of this study was to evaluate how pragmatic are the clinical trials used to build the French High Authority of Health's recommendations on the management of type II diabetes. Methods: Trials from the 2013 Cochrane meta-analysis that led to the 2013 French High Authority of Health's recommendations on the management of type II diabetes were selected. Each trial was analysed by applying the PRECIS-2 tool to evaluate whether the trial was pragmatic or explanatory, according to the nine domains of PRECIS-2. Each domain was scored between 1 (very explanatory) and 5 (very pragmatic) by two blinded researchers, and consensus was reached with a third researcher in case of discrepancy. Median scores were calculated for each of the nine domains. Results: Twenty-three articles were analysed. Eight out of nine domainsnamely eligibility, recruitment, setting, organisation, flexibility of delivery, flexibility of adherence, follow-up, and primary outcomehad a median score of less than 3, indicating a more explanatory design. Only the primary analysis domain had a score indicating a more pragmatic approach (median score of 4). In more than 25% of the articles, data to score the domains of recruitment, flexibility of delivery, flexibility of adherence, and primary analysis were missing. Conclusions: Trials used to build French recommendations for good clinical practice for the management of type 2 diabetes in primary care were more explanatory than pragmatic. Policy-makers should encourage the funding of pragmatic trials to evaluate the different strategies proposed for managing the patient's treatment according to HbA1C levels and give clinicians feasible recommendations.

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The role of pragmatism in explaining heterogeneity in meta-analyses of randomised trials: a protocol for a cross-sectional methodological review

Cited by 15 publications

References 20 publications

Brief Interventions in Primary Care: an Evidence Overview of Practitioner and Digital Intervention Programmes

Brief Interventions in Primary Care: an Evidence Overview of Practitioner and Digital Intervention Programmes

Efficacy and Safety Evaluation of the Various Therapeutic Options in Locally Advanced Cervix Cancer: A Systematic Review and Network Meta-Analysis of Randomized Clinical Trials

How pragmatic are the randomised trials used in recommendations for control of glycosylated haemoglobin levels in type 2 diabetic patients in general practice: an application of the PRECIS II tool

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